Infinite Element Installation And Setup Manual page 2

All rights reserved. Element is a trademark of Infinite Biomedical
Technologies, LLC.
This document provides information for the prosthetist who will be installing
Element and IBT Electrodes.
Contains FCC ID: XDULE40-D2
Infinite Biomedical Technologies, LLC.
8 Market Place, Suite 500
Baltimore, MD 21202
(443) 451-7175
www.i-biomed.com
SRN: US-MF-000007619
Mdi Europa GmbH
Langenhagener Str. 71
30855 Langenhagen
Germany
SRN: DE-AR-000006218
L E G E N D O F SY M B O L S U S E D
Medical Consult Single
Device Instructions Patient,
for Use Multiple
Use
Serial Translated European
Number Authorized
Representative
This symbol is used throughout the guide to indicate important
cautionary information. Text following this symbol should be
read carefully.
Caution: Federal law restricts this device to sale by or on the
order of a prosthestist.
This device includes an RF transmitter or applies radio frequency
electromagnetic energy.
Contains IC: 8456A-LE4D2
www.i-biomed.com/support.html
Keep Distributor Importer CE Mark
Dry
Manufacturer Catalogue Model
Number Number
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Elem ent
I N STA L L AT I O N A N D S E T U P G U I D E
F O R T H E P R O ST H E T I ST
Thank you for choosing Element to provide EMG inputs for an upper limb
myoelectric prosthesis. This guide will familiarize you with Element and help
you install the hardware and software.
Have any questions? We're happy to help. Call us or send us an email.
(443) 451-7175
support@i-biomed.com
I N T E N D E D U S E
The Element system is intended to detect, process, and transmit physiological
signals for use with a prosthesis
I N D I C AT I O N S F O R U S E
The Element system is intended to be used exclusively for myoelectric exo-
prosthetic fittings of the upper limb.
C O N D I T I O N S F O R U S E / PAT I E N T TA R G E T G R O U P
Element is intended for use on one patient only, for users with unliteral or
bilateral amputation, hand, forearm and upper arm amputation or dysmelia.
Use of the product by another person is not approved by the manufacturer.
Installation of the system should be performed exclusively by a licensed
prosthetist or technician. Any unauthorized handling or installation of Element
could void its warranty.
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